The legal relationship between the original designers and manufacturers of medications and the companies that produce generic formulations of the drugs remains tenuous. In some cases, patients have been able to sue the original companies for the effects of generics, while in others judges have ruled that the case only warrants a claim against the makers of the off-brand. In the most recent Reglan case, the latter seems to be the approach taken by plaintiff Susan Swicegood.
Swicegood has filed suit against the makers of a generic version of Reglan, Pliva. She argues that Pliva’s generic version of the anti-heartburn medicine did not include warnings that the medicine is causally linked to Tardive Dyskinesia. The FDA has a long-standing requirement that Reglan and its derivatives carry black-box warnings on the packaging explaining this risk. Black box warnings are meant to convey specific instructions in no uncertain terms, so failing to provide them on packaging is a serious breach of ethical practices.
Part of the problem complicating matters is that Reglan and its derivatives are intended to be prescribed for short periods — usually no more than a few weeks. However, in a significant number of cases, the conditions it is intended to correct are persistent. GERD or acid reflux disease are notoriously chronic conditions, often returning very shortly after medication is discontinued. Thus, in about 20 percent of cases, doctors end up prescribing the medication for longer periods. This could potentially raise the question of improper use as a tool by the defense. The key to this argument will be whether Tardive Dyskinesia can be demonstrated to occur even in patients taking the medicine for the recommended period of time.
A judge has ruled that the assorted pieces of Reglan litigation cannot proceed as a single, consolidated suit for pretrial matters earlier this year. This means Swicegood and other plaintiffs must go through the system individually, which means that progress in these matters could ultimately take years.
—-
